Electronic Proactive Outreach for Smokers With COPD

NCT04462289 | Completed Results

• 1 other identifier: CDX 20-001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases, with 90% of cases directly attributable to smoking. Unfortunately, many patients continue to smoke and have an urgent need to quit. Proactive tobacco treatment programs identify patients outside of a routine clinical appointment and engage them in making a supported quit attempt. Most previous research of proactive tobacco treatment has used telephone outreach, which can be resource intensive. Electronic methods (texting, secure messaging) may be effective while requiring fewer resources. In this study, the investigators will adapt a clinically available motivational texting program with content tailored to smokers with COPD. First, information will be gathered from smokers with COPD and the medical staff who care for them to adapt the program for electronic delivery. Then, the program will be pilot-tested. Smokers with COPD will be randomly assigned to either usual medical care or the outreach intervention, with goals to increase participation in smoking cessation programs, quit attempts, and successful cessation.

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Keywords

smoking cessation; Pulmonary Disease, Chronic Obstructive; implementation science

Outcome Measures

Primary Outcomes (1)

• Participation in Tobacco Cessation Treatment

  Any participation in tobacco cessation treatment (medication use, counseling)

  6 months

Secondary Outcomes (9)

• 30-Day Abstinence

  6 months

• Quit or Cut Down

  6 months

• 7-day Abstinence

  6 months

• Moved Upward on the Quit Ladder

  6 months

• Cut Down in Heaviness of Smoking

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

Randomly assigned sample who will receive usual care for tobacco cessation treatment

Proactive Outreach

EXPERIMENTAL

Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.

Behavioral: Proactive Outreach

Interventions

Proactive Outreach BEHAVIORAL

Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs

Proactive Outreach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans active in clinical care (at least one primary care or pulmonary visit within the past year)
• Past-year smoking status in the electronic health record indicating current smoking, confirmed on enrollment call
• Diagnosed with COPD (2 International Classification of Diseases (ICD)-10 diagnoses of COPD within the past 2 years)
• Currently enrolled in MyHealtheVet secure messaging

You may not qualify if:

• Already enrolled in behavioral VA tobacco treatment
• Enrolled in hospice
• Undergoing active cancer treatment
• Advanced dementia
• Unable to communicate in English

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Health Behavior

Limitations and Caveats

This was a small, single center pilot including mostly white, male Veterans. Results may therefore not be generalizable to other settings. However, this is a group expected to be particularly refractory to treatment. We chose to make relatively moderate adaptations to an existing protocol and there may have been other areas that would have benefitted from further tailoring. Outcomes were relatively short and measured by self-report.

Results Point of Contact

• Title: Dr. Anne Melzer
• Organization: Minneapolis VA Health Care System

anne.melzer2@va.gov

6124674413

Study Officials

• Anne C. Melzer, MD MS

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Patient-level randomized pilot

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: September 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: August 22, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)